Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrocardiograph
510(k) Number K933404
Device Name CRITIKON CENTRAL STATIN MONITOR
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Applicant Contact ANNETTE M HILLRING
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 31800
Tampa,  FL  33631
Correspondent Contact ANNETTE M HILLRING
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
DRG  
Date Received07/12/1993
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-